(415 days)
Specific indications: used to apply an electrical current to electrodes on patient's skin at some limited ● positions to function as:
- Relaxation of muscle spasms;
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion.
Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for . the treatment of medical diseases and conditions.
Home Care various models of Powered Muscle Stimulator, HT-329M1, HT-329M2, HT-329M3, and HT-329M4
The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study proving device performance. This document is a regulatory approval notice, indicating that the Home Care Powered Muscle Stimulator (various models) is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC results from this document.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).